Bayer and ArcherDX Announce Global Collaboration to Develop Next-Generation Sequencing (NGS)-based Companion Diagnostic (CDx) for VITRAKVI® (larotrectinib)

Bayer and ArcherDX, Inc. have announced a global collaboration for the development and commercialization of a next-generation sequencing (NGS)-based companion diagnostic (CDx) for Vitrakvi® (larotrectinib). The primary objective of the collaboration is to broaden patient access to comprehensive genomic testing inclusive of neurotrophic receptor tyrosine kinase 1 (NTRK1), NTRK2 and NTRK3 gene fusions and to help improve identification of appropriate treatment options for patients with TRK fusion cancer which can lead to meaningful treatment options.

Vitrakvi is indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are either metastatic or where surgical resection will likely result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.1

Genomic cancer testing helps detect changes in a tumor’s DNA, called genomic profiling, that can determine how the cancer behaves and why it grows or spreads.2 Almost 50 percent of patients who undergo genomic cancer testing may have actionable genomic alterations, meaning the alterations can be matched to treatments that have been approved or are in clinical trials.3,4 Genomic cancer testing has already impacted patient cancer care in both common and rare malignancies. This has allowed for the identification of personalized treatment options.5 However, studies show that only a small percentage of cancer patients undergo such testing.5 It is therefore critical that testing becomes part of routine clinical practice to help guide treatment choice.

“In order to help more patients to benefit from Vitrakvi, a treatment with efficacy in TRK fusion cancer, broader access to high quality testing via next-generation sequencing is of key importance,” said Robert LaCaze, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of the Oncology Strategic Business Unit at Bayer. “The collaboration with ArcherDX perfectly complements Bayer’s CDx strategy and fits our ambition to further advance the field of genomic testing and personalized treatment, providing the right treatment to the right patient for patients with cancer.”

“Barriers currently exist that inhibit the broad adoption of genomic testing to inform treatment decisions. A kit-based CDx that is tumor agnostic and detects all NTRK gene fusions will enable high-quality genomic testing to be deployed in regional and community settings, where 85 percent of cancer patients receive care.6 For these patients, our technology provides RNA-based profiling for the detection of actionable fusions across known and novel NTRK fusion partners,” said Jason Myers, Chief Executive Officer and co-founder, ArcherDX. “We are pleased to collaborate with Bayer to address their medical need and accelerate access to therapy.”

NGS-based CDx tests aim to unlock molecular information from each patient’s tumor genome to guide treatment decisions for cancer therapies. ArcherDX is developing and pursuing regulatory clearances for an in vitro diagnostic (IVD), a comprehensive NGS-based therapy selection product that utilizes Archer’s proprietary Anchored Multiplex PCR (AMP™) technology to measure clinically relevant genomic mutations for tumor profiling and CDx from both tissue and blood.

ArcherDX and Bayer are developing a kit-based CDx to detect NTRK gene fusions, including NTRK1, NTRK2, NTRK3 for Vitrakvi and plan to seek approval in different markets, including the European Union (EU), U.S. and Japan. The CDx version of this panel will allow local laboratories to provide referring physicians with potentially actionable genomic information, so that appropriate patients can be matched to specific therapeutic options based on their genomic findings.

The Pharmaceuticals Business Development & Licensing team of Bayer facilitated this collaboration. Financial terms of the agreement were not disclosed.


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